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Can a newer drug outperform the standard for chronic myeloid leukemia?

NCT ID NCT03722420

Disease control Sponsor: Il-Yang Pharm. Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This phase III trial compares two oral drugs, radotinib and imatinib, in adults newly diagnosed with chronic myeloid leukemia in its chronic phase. Researchers want to see if radotinib, taken twice daily, achieves a deeper molecular response at 12 months than imatinib, taken once daily. The study enrolls about 238 patients in China who have not yet received treatment for this leukemia. If radotinib proves superior, it could become a new first-line option for these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radotinib
What this could lead to
If radotinib works better than imatinib, it could offer a new first-line option for people with chronic myeloid leukemia, potentially improving long-term disease control.
What could go wrong
This is a phase III trial, but success is not guaranteed. Radotinib may not prove more effective or may cause more side effects than imatinib. Results apply only to the Chinese patient group studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 238 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. China who are 18 years of age or older. 2. Eastern cooperative oncology group (ECOG) score 0, 1, or 2. 3. Patients with confirmed diagnosis of CML-CP within last 6 months. 4. Patients with cytogenetically confirmed Ph+ CML in chronic phase 5. Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2. 6. Patients with adequate organ function. 7. Women of childbearing potential should have negative serum or urine pregnancy test within 14 days before study entry. 8. Patients providing written informed consent before initiation of any study-related activities. Exclusion Criteria: 1. Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML. 2. Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells 3. Concurrently clinically significant primary malignancy 4. Patients who previously received radiotherapy 5. Patients with impaired cardiac function. 6. uncontrolled chronic medical condition

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia, chronic phase

Contacts and locations

Locations

  • Peking University People's Hospital(北京大学人民医院)

    Beijing, 100044, China

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